Grace periods in comparative effectiveness studies of sustained treatments.

View Abstract

Researchers are often interested in estimating the effect of sustained use of a treatment on a health outcome. However, adherence to strict treatment protocols can be challenging for individuals in practice and, when non-adherence is expected, estimates of the effect of sustained use may not be useful for decision making. As an alternative, more relaxed treatment protocols which allow for periods of time off treatment (i.e. grace periods) have been considered in pragmatic randomized trials and observational studies. In this article, we consider the interpretation, identification, and estimation of treatment strategies which include grace periods. We contrast grace period strategies which allow individuals the flexibility to take treatment as they would naturally do, with grace period strategies in which the investigator specifies the distribution of treatment utilization. We estimate the effect of initiation of a thiazide diuretic or an angiotensin-converting enzyme inhibitor in hypertensive individuals under various strategies which include grace periods.

Investigators
Abbreviation
J R Stat Soc Ser A Stat Soc
Publication Date
2024-01-22
Volume
187
Issue
3
Page Numbers
796-810
Pubmed ID
39281783
Medium
Electronic-eCollection
Full Title
Grace periods in comparative effectiveness studies of sustained treatments.
Authors
Wanis KN, Sarvet AL, Wen L, Block JP, Rifas-Shiman SL, Robins JM, Young JG